Cleared Traditional

CARDIZYME PLUS LD #65094/93 (K832314) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K832314 · Em Industries, Inc. · Chemistry device
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Sep 1983
Decision
49d
Days
Class 2
Risk

K832314 is an FDA 510(k) clearance for the CARDIZYME PLUS LD #65094/93. Classified as Electrophoretic, Lactate Dehydrogenase Isoenzymes (product code CFE), Class II - Special Controls.

Submitted by Em Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 1, 1983 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1445 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Em Industries, Inc. devices

Submission Details

510(k) Number K832314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1983
Decision Date September 01, 1983
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1445
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes

All 15
Devices cleared under the same product code (CFE) and FDA review panel - the closest regulatory comparables to K832314.
TITAN GEL LDH REP SYSTEM
K873386 · Helena Laboratories · Oct 1987
CK/LD BUFFER (CAT. NO. 5808)
K861750 · Helena Laboratories · May 1986
TITAN GEL ISO DOT LDH KIT
K842669 · Helena Laboratories · Nov 1984
TITAN GEL LDH ISO-ENZYME CONTROL
K830872 · Helena Laboratories · Apr 1983
PARAGON ELECTROPHORESIS LACTATE REAG.KIT
K802628 · Beckman Instruments, Inc. · Dec 1980